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NCT06493825 · ClinicalTrials.gov registry record · NA
Mindfulness Application Effects on Mental Health Symptoms in Children With Severe Tinnitus and Misophonia
A NA study of Tinnitus and Misophonia, sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT06493825: Recruiting NA study of Tinnitus and Misophonia, sponsored by University of Colorado, Denver.
NCT06493825 is a NA study of Tinnitus and Misophonia that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 30 participants, below the 12,618-participant average among 24 other Tinnitus trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06493825, a NA study of Tinnitus and Misophonia, is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
Children with "bothersome" tinnitus and misophonia have elevated anxiety and depression symptoms. The mainstay therapy for adults and children with these disorders is cognitive behavioral therapy (CBT). CBT resources are expensive and scarce for the pediatric population. Immersive virtual reality (IVR) has been shown in the adult population to be a proxy for CBT for several mental health disorders. There is sufficient published evidence that IVR is useful in treating adults with anxiety and depression disorders. However, the evidence in children in treating either anxiety and depression symptoms or disorder is scant. Our group views IVR application as a promising medical device to decrease anxiety and depression scores in children with tinnitus and misophonia disorders. This is a randomized placebo control (single-blinded to the study subjects) study in which there will be a 2:1 ratio between the experimental and placebo subjects, receiving either active IVR or placebo exposure. A total of 30 subjects with 20 experimental (10 tinnitus, 10 misophonia subjects) and 10 placebo (5 tinnitus and 5 misophonia subjects) will enroll in this randomized clinical trial. Assessment of change of quality of life, anxiety and depression symptoms will be based on 5 validated instruments. The 5 validated instruments are: Tinnitus Functional Index (TFI), Amsterdam Misophonia Scale (A-MIS-S), Pediatric Quality of Life PEDQL), Screen for Child Anxiety Related Emotional Disorders (SCARED) and Short Mood and Feelings Questionnaire (SMFQ).
Primary Outcome
TFI measures the severity of tinnitus symptoms across several domains with a score range 0 to 90. The higher the score, the more dysfunction a subject is affected by tinnitus.
Conditions Studied
Interventions
- OTHER Aurora Mindfulness app versus sham
Study Locations (1)
Colorado
- Children's Hospital Colorado - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-09-01 |
| Est. Completion | 2025-12-15 |
| Phase | NA |
What NCT06493825 shows while recruiting
NCT06493825 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 12,618-participant average among 24 other Tinnitus trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with Tinnitus appearing as the primary indexed condition, and to 1 intervention - of which Aurora Mindfulness app versus sham is the first listed.
NCT06493825 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT06493825 about?
NCT06493825 is a clinical study titled "Mindfulness Application Effects on Mental Health Symptoms in Children With Severe Tinnitus and Misophonia". Children with "bothersome" tinnitus and misophonia have elevated anxiety and depression symptoms. The mainstay therapy for adults and children with these disorders is cognitive behavioral therapy (CBT). CBT resources are expensive and scarce for the pediatric population. Immersive virtual reality (I...
What is the current status of trial NCT06493825?
This trial is currently recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2024-09-01. Estimated completion is 2025-12-15.
What conditions does trial NCT06493825 study?
This clinical trial studies the following conditions: Tinnitus, Misophonia.
What interventions are being tested in trial NCT06493825?
The interventions under investigation include: Aurora Mindfulness app versus sham (OTHER).
Who is sponsoring clinical trial NCT06493825?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06493825 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06493825's enrollment target sits among peer trials
30 21st of 24 higher than 4 of 24 other Tinnitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Tinnitus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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